NCT03437681

Brief Summary

This study plans to learn more about how sleep loss impacts the way the body responds to sugar. This work will have important implications for development of treatments and countermeasures for people who are not able to get enough sleep for various reasons.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

February 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

6.4 years

First QC Date

February 6, 2018

Last Update Submit

November 28, 2023

Conditions

Keywords

SleepBlood Sugar

Outcome Measures

Primary Outcomes (1)

  • Change in insulin sensitivity

    Insulin sensitivity measured by hyperinsulinemic euglycemic clamp.

    One week

Secondary Outcomes (5)

  • Changes in macrovascular function

    One week

  • Changes in microvascular function

    One week

  • Changes in cognitive abilities

    One week

  • Changes in circadian rhythms

    One week

  • Changes in metabolic tissue function

    One week

Study Arms (1)

Insufficient sleep

EXPERIMENTAL

Each participant will receive 4 nights of insufficient sleep.

Behavioral: Insufficient sleep

Interventions

Four days of insufficient sleep

Insufficient sleep

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, lean participants.
  • No regular physical activity (\<20 minutes/day). No exercise will be allowed for 3 days prior to study start.
  • Habitual sleep duration between 7-9.25h. Subjects must also be willing and able to keep a 9h time-in-bed schedule for 1 week prior to study admission.
  • Potential subjects must have lived at Denver altitude or higher for at least 3 months to inpatient study.

You may not qualify if:

  • Current or history of any clinically significant medical, psychiatric, or sleep disorder.
  • Use or history of any drugs, medications, supplements, caffeine, and alcohol.
  • Current or history of shiftwork in six months prior to laboratory study.
  • Travel more than one time zone in three weeks prior to laboratory study.
  • Blood donation in the 30 days prior to inpatient study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Links

Study Officials

  • Josiane L. Broussard, PhD

    University of Colorado, Boulder

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: The project is a within-subject consecutive design examining 18 healthy individuals after baseline and after 4 nights of insufficient sleep.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 19, 2018

Study Start

February 12, 2018

Primary Completion

June 30, 2024

Study Completion

December 30, 2024

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations